BEUDAMED
    FDA Adverse Event Summary report: N

    ITOVI TRACKER / SCANNER

    MDR report key: 7665753 · Received July 5, 2018

    Report

    Report Number
    MW5078276
    Date Received
    July 5, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ITOVI
    Product Code
    GZO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT RECALL ITOVI IS RECALLING THE ITOVI SCANNER AFTER IT RECENTLY DISCOVERED THAT THIS DEVICE AND ITS ACCESSORIES MAY NOT HAVE BEEN MANUFACTURED ACCORDING TO CURRENT GOOD MFG PRACTICES, INCLUDING THE 21 CFR 820 QUALITY SYSTEM REGULATION. IN ADDITION, THREE COMPLAINANTS HAVE INFORMED THE COMPANY OF ALLEGED ELECTRICAL SHOCK WHEN USING THE DEVICE. ALTHOUGH WE WERE UNABLE TO REPRODUCE THE ISSUE, ITOVI TAKES THESE ALLEGATIONS VERY SERIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507597 ITOVI TRACKER / SCANNER DEVICE GALVANIC SKIN RESPONSE MEASUREMENT GZO ITOVI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR